E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to compare the effect on glycaemic control of IDeg versus IGlar 100U/mL
in a population of T2DM subjects with or without oral anti-diabetic drugs (OADs), using FGM. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, age greater than or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening.
- Subjects fulfilling at least one of the below criteria:
- Experienced at least one severe hypoglycaemic episode within the last year prior to screening (according to the American Diabetes Association definition, January 2018).*
- Moderate renal impairment defined as estimated glomerular filtration rate (eGFR) value of 30-59 mL/min/1.73 sqm as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 at screening.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8 at screening.
- Treated with insulin for more than 5 years.
- Episode of hypoglycaemia (defined a glucose alert value of 70 mg/dL (3.9 mmol/L) or less, i.e. Level 1) within the last 12 weeks prior to screening visit.
- Treated with any basal insulin greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs:
- Metformin
- Dipeptidyl peptidase-4 inhibitor
- Sodium-glucose co-transporter 2 inhibitor
- Alpha-glucosidase-inhibitors (acarbose)
- Thiazolidinediones
- Marketed oral combination products only including the products listed above
- Glycated haemoglobin (HbA1c) less than or equal to 9.5% (80 mmol/mol) at screening confirmed by central laboratory analysis.
- Body mass index (BMI) less than or equal to 45 kg/sqm.
*Hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery |
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E.4 | Principal exclusion criteria |
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, intermittent bolus insulin treatment for periods of no longer than 14 days are permitted prior to the day of screening.
- Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and run-in. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of time spent in glycaemic target range 70-180 mg/dL (3.9–10.0 mmol/L) both
inclusive, using FGM. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the 2-week maintenance periods (week 16-17 in treatment period-1 and week 34-35 in treatment period-2). |
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E.5.2 | Secondary end point(s) |
1. Percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9–7.8 mmol/L) both inclusive, using FGM.
2. Percentage of time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am – 05:59 am both inclusive), using FGM.
3. HbA1c (% and mmol/mol).
4. Mean glucose levels (mg/dL and mmol/L), using FGM. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2 and 4: During the 2-week maintenance periods (week 16-17 in treatment period-1 and week 34-35 in treatment period-2).
3: After the 2-week maintenance periods (week 16-17 in treatment period-1 and week 34-35 in treatment period-2). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
European Union |
South Africa |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 28 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 28 |